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U.S. Department of Health and Human Services

Class 2 Device Recall AMS 700 CX/LGX Rear Tip Extenders

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 Class 2 Device Recall AMS 700 CX/LGX Rear Tip Extenderssee related information
Date Initiated by FirmOctober 09, 2026
Date PostedNovember 09, 2026
Recall Status1 Open3, Classified
Recall NumberZ-0396-2027
Recall Event ID 100095
Product Classification Prosthesis, penis, inflatable - Product Code JCW
ProductAMS 700 CX/LGX Rear Tip Extenders (RTEs), Snapcone, CX/LGX, 0.5 cm. UPN: 72404320.
Code Information UPN: 72404320. Primary GTIN: 00878953004044. Unit of Use GTIN: 00878953008981. Batch Number: 39046410. Lot Numbers: 1100949284, 1100949288, 1100949293, 1100949299, 1100949301, 1100949322, 1100949328.
FEI Number 3005099803
Recalling Firm/
Manufacturer		 Boston Scientific Corporation
100 Boston Scientific Way
Marlborough MA 01752-1234
For Additional Information ContactClara Johnson
508-683-4000
Manufacturer Reason
for Recall		Potential for the Rear Tip Extender (RTE) size contained within the package to differ from the size identified on the product labeling. Certain packages labeled as containing a 0.5 cm RTE may contain a 1.5 cm RTE.
FDA Determined
Cause 2		Under Investigation by firm
ActionBoston Scientific notified consignees on about 10/09/2026 via mailed "Urgent Medical Device Removal - Immediate Action Required" letter. Consignees were instructed to cease further use or distribution of the affected units, place a copy of the customer notification in the patient's file if it is suspected that an incorrectly sized RTE was implanted, complete and return the provided Reply Verification Tracking Form, return all affected units on hand, and forward the notification letter to any relevant personnel or facilities to which product was transferred.
Quantity in Commerce7 units
DistributionWorldwide - US Nationwide distribution in the states of CA, NC, PA, TX, UT, WI and the country of France.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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